North York, Ontario
IT Project Manager – Lab Systems Implemenatation
eq# 9842681 (Project Manager II)
ITS Project Manager – QC Lab Systems
Pharmaceutical Manufacturing firm
35 hours per week
The Information Technology and Solutions (ITS) department supports the major business areas within company’swith dedicated teams. The ITS Industrial team is seeking external support for two projects required by the Quality Control (QC) department in Toronto:
- Parallel Line Analysis (PLA) v3.0 Roll-out: deployment of Stegmann PLA software, utilizing the validated global system from ITS R&D.
- SoftMax Pro v7.1 Upgrade: upgrade of Molecular Devices SoftMax Pro software from v5.4 to v7.1 (to be implemented and validated either as a local system or co-developed with global ITS as a global system; decision to be made during project execution).
The ITS Project Manager position is ultimately responsible for ALL aspects of the project. This position will lead and coordinate the project team including members from ITS, QC and Site Quality & Validation teams in designing, building, validating, and deploying the PLA and SoftMax Pro solutions for the QC department.
- Execute projects according to approved Project Plans. Coordinate and track business and ITS activities required to deliver project.
- Maintain project schedules following ITS Project Management Methodology (PUMA) to ensure projects are delivered on time and on budget per defined scope. Manage issues impacting project schedule as they arise and proactively propose solutions. Identify, track and manage project risks.
- Monitor and control the project progress and provide visibility on status. Organize, prepare and report to the Project Steering Committee.
- Facilitate project meetings, including providing agendas, meeting minutes, and ensuring that meetings are effective.
- Coordinate with external vendors, ITS R&D, ITS quality, global quality, site quality, and internal ITS infrastructure teams as needed to meet the project deliverables.
- Work closely with QC department and ITS team to document requirements, define business processes, and determine configuration settings.
- Coordinate with Validation Expert (VEX), User Project Lead (UPL), and ITS Project Lead (IPL) to produce, review, and obtain approval for technical and validation documentation such as User Requirements Specifications, Functional Specification, Design Specifications, Protocols, Test Scripts, and Installation Procedures as required by the project. Ability to assist in documentation creation as required.
- Ensure support model is identified for delivered solutions and coordinate transition to support organizations as required.
- Understand the company’s computer validation process & the company’s PUMA methodology for executing projects.
The assignment is for 10 months, beginning March 2020 and extending through to December 2020.
- Deliver PLA v3.0 and SoftMax Pro v7.1 for Toronto QC Department with all required validation deliverables as defined in project validation plans.
- Provide project status reports and prepare Steering Committees.
POSITION REQUIRED (ROLE)
- ITS Project Manager for QC lab systems
The candidates must possess the following skills and experience:
- 5+ years experience as ITS Project Manager
- BA/BS Sciences (Chemistry, Biology, etc.), Information Systems, or Business Studies
- Strong technical documentation, communication, and reporting skills
- Strong skills with database structures
- Software administration experience
- Thorough knowledge of all desktop personal productivity software (i.e. Office, Project, Visio)
- Computer Systems Validation experience
- Prior experience in GxP FDA-regulated environment
- Ability to manage relationships with external vendors
SCOPE OF WORK
The scope of this effort encompasses the activities required to manage and contribute to various stages (Initiation, Requirements Definition, Design, Build, Acceptance, and Release and Deploy) of the PLA Extensions project in the ITS Industrial area. This position is in Toronto, Ontario and reports to the ITS Industrial Quality Domain Head. No travel is necessary for this project resource.